MAUDE Adverse Event Report: DERMACLIP US LLC DERMACLIP LARGE 3 CLIP HOSPITAL 61004

Model Number DCSLC3UPKBX01-MX

Device Problem Use of Device Problem (1670)

Patient Problem Wound Dehiscence (1154)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is underway.The dermaclip device is classified with fda as a class 1 medical device, product code kgx, 510(k) exempt.Dermaclip large 3 clip hospital devices come in a box of 12 packages, three large clips per package.Seven dermaclip large clips from three separate packages were used on the patient so dermaclip us is filing three mdr reports, one for each package of three clips.This event concerns the release of the adhesive on skin closure devices on a c-section incision.Prior to application, the incision was closed with subdermal and sub-cuticular suturing.Only the final dermal layer was closed with the dermaclip devices.After discovery of the released adheasive, the dermal layer was closed with sutures.Based upon the opinion of our chief medical officer, the patient was not at risk of serious injury or death as a result of the release of the adhesive.Devices from packages stored under similar conditions to the packages containing the devices that failed were tested against packages stored by the manufacturer under temperature controlled conditions.The conclusion of that testing was: "using a two-sample t-test, the mean from peel adhesive doesn't differ significantly between the two groups.Confidence level 95% p-value 0.0501." adhesive testing was performed on august 28, 2019, which is part of the larger investigation that is still underway.Further discussions with the patient's obgyn and various people involved.Once dermaclip us has finished its investigation we will send a follow up report to this mdr.This event is related to mfr.Report # 3011656357-2019-00001 and mfr.Report #3011656357-2019-00002.Also please note this filing patient code should be (b)(4), i could not get that code to get recorded on this form.

Event Description

Three packages of dermaclip large hospital devices for a total of seven dermaclip devices, were applied as the skin closure for a c-section incision after precedent closure through subcuticlar suturing.Twenty-eight hours after the surgery, the patient showered.After showering, it was discovered that the adhesive attaching the dermaclip devices below the incision line uniformly released.Patient reported the incident to the nurse and the attending physician replaced the dermaclip devices with sutures.Since each package contains three dermaclips devices, dermaclip us is filing one report for each package of the three dermaclip devices.This report is identical to mfr.Report #3011656357-2019-00001 and mfr.Report #3011656357-2019-00002.

• Brand Name: DERMACLIP LARGE 3 CLIP HOSPITAL 61004
• Type of Device: DERMACLIP LARGE 3 CLIP HOSPITAL
• Manufacturer (Section D): DERMACLIP US LLC; 730 n post oak rd; ste 202; houston TX 77024
• Manufacturer Contact: catherine fonfara ; 730 n post oak rd.; ste. 202; houston, TX 77024 ; 7136823185
• MDR Report Key: 9099965
• MDR Text Key: 218019781
• Report Number: 3011656357-2019-00003
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2021
• Device Model Number: DCSLC3UPKBX01-MX
• Device Catalogue Number: 61004
• Device Lot Number: S191245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 68